Rapamycin / Everolimus in 1 year of Cancer Therapy

There is a clinical trial is about to conclude in 2022 (EVEREST).

This study is on 1545 kidney cancer patients who’ve undergone surgery to remove their tumor.

Purpose The goal of the study is to compare how long you live without return of the tumor and how long you live in patients with renal cell cancer randomly (like the flip of a coin) assigned to 54 weeks of everolimus versus 54 weeks of placebo (an inactive drug) after complete or partial removal of your kidney by surgery. The study will also compare the amount and type of side effects between the two study arms.

Dosing: 1 yrs of daily 2.5-10mg Everolimus use. Then follow them for 10 yrs.

It’ll be interesting to see if non-cancer mortality will drop after 1 yr of intense Evorolimus.

Upcoming conference paper: https://meetings.asco.org/abstracts-presentations/207883

Background info:

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10mg/day, trough levels 15 ng/ml, lots of dose reductions and dose limiting toxicities. 40% of participants quit the study after starting!

Any insight on why Everolimus being used?

How do we think about dose scaling in prevention vs curation?

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It was originally approved as a cancer drug, I believe, and thats what its used for most predominantly I think.

OK, I was wondering, with other mTOR inhibitors out there, why specifically Everolimus.

The only rapamycin like drugs are everolimus and temsirolimus. The second is injection and rapamycin has had a ton of research already.

And everolimus has just gone off patent so will be cheap.

Everolimus’ half life is 28 hours compared to 62 hours of sirolimus. Everolimus can be dosed more frequently. It also has higher bioavailability than sirolimus.

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